Drug factory · FDA FEI 3005712028
Molecular Imaging Program At Stanford
1201 Welch Road, Palo Alto, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 4, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2010: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fludeoxyglucose F-18 | Makes it | MIPS Cyclotron & Radiochemistry Facility | 69587-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 4, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Nov 3, 2015 | No problems found | Drug Quality Assurance | — |
| Oct 6, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 4, 2024 inspection
- Electronic records 21 CFR 11
Electronic records are used, but they do not meet system access limitation, audit trail, employee accountability/responsibility policy and systems documentation control requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records. - Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures. - Supplies adequately controlled 21 CFR 212.60(d)
Your quality of supplies used in your testing procedures are not adequately controlled.
Registered with FDA for: positron emission tomography drug production.